The purpose of this interventional study was to check if the elimination of gluten from the diet of women with autoimmune thyroiditis affects their health and thyroid function, quality of life, and the gut microbiome composition. The main questions it aimed to answer were: * Does the gluten-free diet worsen the gut microbiome composition? * Does the gluten-free diet improve thyroid function, measured as thyroid stimulating hormone (TSH), thyroid hormones thyroxine (FT4) and triiodothyronine (FT3), thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibodies (TgAb)? * Does the gluten-free diet improve the quality of life? Participants: * followed normocaloric gluten-free diet for 8 weeks * after first 4 weeks were randomly assigned to one of two groups. One group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch (placebo). Blood and stool samples were collected before diet (T0), after 4 weeks (T1) and after 8 weeks of diet (T2) (total of 3 samples per participant). Also each participant completed the ThyPROpl quality of life assessment questionnaire for patients with thyroid diseases in three time points: before the diet (T0), after 4 weeks (T1) and after 8 weeks of the diet (T2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
31
Diet with gluten elimination followed by all participants for 8 weeks
2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).
Medical University of Gdańsk
Gdansk, Poland
Change in gut microbiome composition
Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.
Time frame: Baseline (T0) to week 4 (T1)
Change in gut microbiome composition
Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid stimulating hormone (TSH)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid stimulating hormone (TSH)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone thyroxine (FT4)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid hormone thyroxine (FT4)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone triiodothyronine (FT3)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid hormone triiodothyronine (FT3)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid peroxidase antibodies (TPOAb)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid peroxidase antibodies (TPOAb)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroglobulin antibodies (TgAb)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroglobulin antibodies (TgAb)
Time frame: Week 4 (T1) to week 8 (T2)
Change in quality of life measured in ThyPROpl questionnaire
ThyPROpl is a linguistically validated version of the original ThyPRO questionnaire. ThyPRO is recommended for the assessment of health-related quality of life in patients with benign thyroid disease. ThyPRO consists of 85 questions summarised in 13 scales measuring aspects of QoL relevant to thyroid patients. Patients are asked to rate their responses for each item on a five-point Likert scale: 0 - not at all; 1 - a little; 2 - some; 3 - quite a bit; 4 - very much. Higher scores mean an improvement in the quality of life.
Time frame: Baseline (T0) to week 4 (T1)
Change in quality of life measured in ThyPROpl questionnaire
ThyPROpl is a linguistically validated version of the original ThyPRO questionnaire. ThyPRO is recommended for the assessment of health-related quality of life in patients with benign thyroid disease. ThyPRO consists of 85 questions summarised in 13 scales measuring aspects of QoL relevant to thyroid patients. Patients are asked to rate their responses for each item on a five-point Likert scale: 0 - not at all; 1 - a little; 2 - some; 3 - quite a bit; 4 - very much. Higher scores mean an improvement in the quality of life.
Time frame: Week 4 (T1) to week 8 (T2)
Change in erythrocyte sedimentation rate (ESR)
Time frame: Baseline (T0) to week 4 (T1)
Change in erythrocyte sedimentation rate (ESR)
Time frame: Week 4 (T1) to week 8 (T2)
Change in C-reactive protein (CRP)
Time frame: Baseline (T0) to week 4 (T1)
Change in C-reactive protein (CRP)
Time frame: Week 4 (T1) to week 8 (T2)
Change in fasting glucose
Time frame: Baseline (T0) to week 4 (T1)
Change in fasting glucose
Time frame: Week 4 (T1) to week 8 (T2)
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